Future access to HIV vaccines. Report from a WHO-UNAIDS Consultation, Geneva, 2-3 October 2000

Results from the first phase III efficacy trial of an HIV vaccine will be available within the next 2-3 years. Thus, it is imperative to start planning now to address how any effective vaccines should be used. In the absence of definitive information on the characteristics of the first generation of HIV vaccines, the following assumptions were made: the vaccine will (i) have only low to moderate efficacy (on the order of 50%); (ii) not be inexpensive (on the order of 10 to 30 US $ per dose); (iii) require multiple doses; and, (iv) at least initially, be available in limited quantities. A vaccine with that profile would not be suitable for general use in all countries, and it might have to be initially targeted to populations at higher risk of HIV infection. These populations will differ from region to region, according to the epidemiological situation. In most high and middle income countries potential target groups for an initial HIV immunization programme would include intravenous drug users, gay men, commercial sex workers, and high-risk heterosexuals, as well as healthcare workers exposed to blood. In sub-Saharan Africa, future HIV immunization programmes might include larger segments of the population. In order to plan future vaccination programmes it is important to estimate the need (size of target population) and the demand (uptake in target populations) for future HIV vaccines. In addition to the public sector demand for an HIV vaccine (to be used in public health programmes), there will also be a private sector demand driven by the willingness and ability of individuals and employers to pay for the vaccine. HIV vaccines would need to be delivered as part of comprehensive HIV prevention packages, including behavioral and health promotion interventions. This would be especially important with vaccines of moderate efficacy, in order to prevent increased risk behavior among vaccine recipients. To avoid false expectations, the vaccine message would need to be recast as part of the total prevention strategy, rather than the "magic bullet" that people have come to expect. Initial deployment of HIV vaccines could proceed through targeted vaccination campaigns, drawing from experience with other vaccines. These campaigns would be complex and expensive, and would require full participation and collaboration from all levels of the community, as well as considerable strengthening of the infrastructures required for vaccine delivery. Current candidate vaccines in phase III trials may not be appropriate for much of Africa and South Asia, two areas most in need of an HIV vaccine. Credible international efforts ('push and pull" mechanisms) are needed to create incentives for the industry to develop vaccines for these regions. Feasible financing mechanisms may have to be established to cover the cost of production and delivery of vaccines, in order to ensure equitable access to HIV vaccines around the world. In parallel to the deployment of the initial vaccine, additional bridging studies and effectiveness trials may be needed to expand vaccine use. Research should also continue at an increased pace to develop new generations of more effective vaccines, especially vaccines appropriate to Africa. Achieving these goals will require real political commitment from government and international organizations, to be materialized in specific actions and budget allocations. The daunting challenge of making future effective vaccines accessible to all populations in need will require a sustained collaborative effort on the part of all parties involved.     

Report from the 12th World AIDS Conference: the psychology of treatment. The difficult road from Geneva

The 12th World AIDS Conference confirmed that a gap still exists between the efforts of developed nations to combat AIDS and developing nations who have little or no access to care. For those who have access, the recommendation of combination antiviral therapy was balanced by questions of how long the effects could be maintained and of the new side effects of treatments. Many of the presentations focused on adherence to drug therapy and detailed whether subjects were complying with treatment regimens. Discussions centered on how an individual's behavior impacts his or her success in maintaining therapy, and also on the product's and health care provider's ability to influence adherence. Solutions for promoting adherence, and minimizing blame for those who have difficulty, were tempered by presentations acknowledging disadvantaged people, even within developed countries, who are unable to receive treatment. Other topics covered were: how and when treatment should begin, who should receive it, psychological and social ramifications of being treated, and methods of supporting patients. Papers were also presented about the effect of treatment on risk behavior, and the level of discussion and agreement among sexual partners to avoid this behavior.     

Treating people with intercurrent infection in HIV prevention trials. Report from a WHO/UNAIDS consultation, Geneva 17-18th July 2003

While broad agreement now exists among sponsors of HIV prevention trials that antiretroviral therapy (ART) and a clinical care package should be provided to those who become infected during the conduct of a trial, certain practical issues remain unresolved, including Who should pay for ART? How long should ART be provided for? Does treatment extend outside of ART? What else should be included in the standard of care package and who should pay for it? Who should provide treatment and care? This report summarizes the discussions from a consultation held in Geneva (17-18 July 2003) organized by the World Health Organization (WHO) and the joint United Nations Programme on HIV/AIDS (UNAIDS). The group discussed issues related to the various types of HIV prevention trials covered - vaccines, microbicides, behavioural - the ethics and legal rational for providing treatment and care as well as relevant economic issues and developments around scale-up of treatment and care in middle- and lower-income countries. Also discussed were policies of certain research agencies, countries and international funding agencies. The implementation of the conclusions which came out of these discussions on the treatment and care for people who become infected during HIV prevention trials requires the active participation of members of the research community, funders of research, local and national governments and industry as well as the individuals or communities participating in the trials.     

Report on HIV/AIDS from IDSA: news from the mile high city

HIV/AIDS was the subject of some of the presentations at the annual meeting of the Infectious Diseases Society of America (ISDA). The most significant presentation was by Dr. Anthony Fauci, who described the possibility of using IL-2 to purge latently-infected CD4 cells. Other presentations covered treatment of primary HIV infection, updates on developments of nucleoside inhibitors, an efavirenz (EFV) update, PCP prophylaxis, care delivery options, and co-infection with tuberculosis.     

Public health considerations for the use of a first generation HIV vaccine. Report from a WHO-UNAIDS-CDC consultation, Geneva, 20-21 November 2002

SUMMARY: To accelerate the development and future availability of safe, effective and affordable HIV vaccines it is essential to address not only the associated biomedical obstacles, but also the logistic aspects that would guide the introduction and use of those vaccines. It is likely that initial vaccines may only be partially effective, and their public health use will have to be carefully considered. This report summarizes the discussions from a consultation held in Geneva (20-21 November 2002) organized by the World Health Organization (WHO), the joint United Nations Programme on HIV/AIDS (UNAIDS) and the US Centers for Disease Control and Prevention (CDC). The group identified a number of logistic issues that need to be addressed to accelerate the development and future availability of HIV vaccines, and made broad recommendations in four different areas: (a) Vaccine manufacturing and licensing; (b) vaccination acceptability and social marketing; (c) immunisation strategies and delivery; and (d) access and economic issues. The implementation of these recommendations will require the participation of multiple stakeholders in the public and private sector, in industrialized and developing countries. These actions will be essential to ensure widespread and rapid access to HIV vaccines globally, soon after their efficacy is demonstrated in clinical trials.     

Partner notification in pregnant women with HIV: findings from three inner-city clinics

British HIV Association guidelines recommend that all HIV-positive pregnant women should be encouraged to disclose their HIV infection to their partner and that this should be viewed as a process rather than an event. The aim of this study was to describe local practice of partner notification (PN) and patterns of disclosure in a group of HIV-positive women in an antenatal setting. A retrospective case note and local pregnancy database review was undertaken. Women who had accessed specialist HIV antenatal care at one of three east London hospitals with an expected delivery date between 1 March 2004 and 30 June 2006 were identified. In total, 145 women were identified. HIV status had not been disclosed to a partner in 19% ( n =27) of case notes reviewed. There was no documented discussion about PN in 18% ( n =26) of case notes. Forty-three per cent ( n =62) of case notes documented that the male partner had accessed HIV testing after PN was discussed. All HIV-positive pregnant women should have a documented discussion about PN. Concurrent HIV testing offered to both partners may improve HIV testing uptake in male partners and should be explored further. Care plans should include screening for intimate partner violence and housing problems; referral pathways should be established clearly when involving other agencies.     

Burden of HIV among young transgender women: factors associated with HIV infection and HIV treatment engagement

Young transgender women (YTW) are disproportionately affected by HIV, however, little is known about the factors associated with HIV infection and treatment engagement. We examined correlates of HIV infection and the steps of the HIV treatment cascade, specifically, being aware of their HIV infection, linked to care, on ART, and adherent to ART. We analyzed the baseline data of Project LifeSkills, a randomized control trial of sexually active YTW recruited from Chicago, Illinois and Boston, Massachusetts. We conducted multivariable Poisson regressions to evaluate correlates of HIV infection and the steps of the HIV treatment cascade. Nearly a quarter (24.7%) of YTW were HIV-infected. Among HIV-infected YTW, 86.2% were aware of their HIV status, 72.3% were linked to care, 56.9% were on ART, and 46.2% were adherent to ART. Having avoided healthcare due to cost in the past 12 months and not having a primary care provider were associated with suboptimal engagement in HIV care. Our results suggest that improving linkage and retention in care by addressing financial barriers and improving access to primary care providers could significantly improve health outcomes of YTW as well as reduce forward transmission of HIV.     

Abused women report greater male partner risk and gender-based risk for HIV: findings from a community-based study with Hispanic women

The purpose of this study was to assess the relationship between intimate partner violence (IPV) and sexual risk in terms of safer sex behaviour and intent, individual and gender-based HIV risk factors, and male partner HIV risk, among a lower-income community-based sample of Hispanic women reporting a current male sexual partner. Baseline survey data on HIV-related behaviours and risk factors gathered from participants (N=170) of an HIV intervention evaluation study for Hispanic women were used for current analyses. Participants were age 18-36 years, predominantly born outside of the continental US (88.8%) and not English fluent (68.2%). Adjusted logistic regression analyses and 95% confidence intervals were conducted to assess the relationships between male-perpetrated IPV in the past three months and sexual risk variables. One-fifth (21.2%) of the sample reported male-perpetrated IPV in the past three months. Abused women were significantly more likely than those not abused in the past three months to report high STD/HIV risk perceptions (OR=3.02, 95% CI=1.33-6.88), gender-based risk including sexual control by male partners (OR=3.09, 95% CI=1.41-6.76) and male partner risk including male infidelity (OR=4.58, 95% CI=1.57-13.32). Results support the need for emphasis on IPV prevention within HIV prevention programmes and demonstrate the need for HIV prevention efforts directed at men with a history of IPV perpetration.     

Couple counselling and testing for HIV at antenatal clinics: views from men, women and counsellors

The purpose of this study was to gain insight from views of Tanzanian men and women on couple voluntary counselling and testing (CVCT) for HIV at antenatal clinics (ANC) in Tanzania. Data collection was through focus group discussions with women aged 25-48 years (n=8), women 18-24 years (n=10), HIV counsellors (n=11), men aged 20-34 (n=8) and men aged 35-75 years (n=8) and in-depth interviews (IDI) with five men and eight women. Participants were asked their views concerning men volunteering for CVCT for HIV, motivation of couples to receive results together and effective ways of counselling sero-discordant couples. Many participants agreed on the importance of incorporating CVCT at ANC, while others expressed reservations due to the cultural belief that ANC is for women. The importance of love, care and respect between sero-discordant couples was stressed; nonetheless, many anticipated that disclosure of HIV-positive status to an HIV-negative spouse could result in abandonment, divorce or violence against the woman whether she was sero-negative or -positive. Couple counselling and testing at ANC incorporating the suggestions made by study participants could become an important intervention for the prevention of HIV transmission and maintenance of good relations between sero-discordant partners.     

Behavioural changes in intravenous drug users in Geneva: rise and fall of HIV infection, 1980-1989

In the early 1980s, more than 90% of intravenous drug users (IVDUs) shared needles and syringes in Geneva. The prevalence of antibodies to HIV in the sera of outpatient IVDUs increased from 6% in 1981 to 38% in 1983; it was, however, still only 37% in 1988. IVDUs starting methadone maintenance in 1987-1989 had a seroprevalence rate of 22%. In 1989 the percentage of IVDUs exchanging syringes and needles fell to only 5% of seropositive addicts. Only one seroconversion was observed in 1094 patient-months of observation in 1988-1989, which was probably due to sexual contact. The evidence suggests that, in the IDVUs studied, transmission of HIV has diminished since the early 1980s.